Анализ применения селективного модулятора костимуляции Т-лимфоцитов абатацепта в лечении ревматоидного артрита: данные международной клинической практики
https://doi.org/10.33667/2078-5631-2019-1-18(393)-13-23
Аннотация
В данной статье приведены результаты международных исследований, посвященных изучению эффективности, безопасности АБЦ и выявлению возможных предикторов хорошего ответа на терапию данным препаратом в условиях реальной клинической практики.
Об авторах
М. А. Борисова
ФГБНУ «Научно-исследовательский институт ревматологии имени В. А. Насоновой»
Россия
Россия
м. н. с. лаборатории изучения коморбидных инфекций и мониторинга безопасности лекарственной терапии
г. Москва
Г. В. Лукина
ФГБНУ «Научно-исследовательский институт ревматологии имени В. А. Насоновой»; ГБУЗ «Московский клинический научно-практический центр имени А. С. Логинова» Департамента здравоохранения г. Москвы
Россия
Россия
д. м. н., проф., зав. научно-исследовательским отделом ревматологии
г. Москва
Список литературы
1. Schiff M. M., Bessette L. Evaluation of abatacept in biologic-naïve patients with active rheumatoid arthritis. Clinical Rheumatology, 29, 583–591. DOI: 10.1007/s10067–009–1363–0.
2. Александрова ЕЛ, Новиков АА, Насонов ЕЛ. Роль Т-клеток в патогенезе ревматоидного артрита. Науч-практич ревматол 2010; 4; 2: 3–9
3. Cope AP, Schulze-Koops H, Aringer M. The central role of T cells in rheumatoid arthritis. Clin Exp Rheumatol. 2007 Sep-Oct; 25 (5 Suppl 46): S 4–11.
4. Korhonen R, Moilanen E. Abatacept, a novel CD 80 / 86-CD 28 T cell co-stimulation modulator, in the treatment of rheumatoid arthritis. Basic Clin Pharmacol Toxicol. 2009 Apr; 104 (4): 276–84. DOI: 10.1111/j.1742–7843.2009.00375.x.
5. Kremer JM, Genant HK, Moreland LW et al. Effects of Abatacept in Patients with Methotrexate-Resistant Active Rheumatoid Arthritis: A Randomized Trial. Ann Intern Med. 2006; 144: 865–876. DOI: 10.7326/0003–4819–144–12–200606200–00003.
6. Kremer JM, Genant HK, Moreland LW, et. al. Results of a two-year follow up study of patients with rheumatoid arthritis who received a combination of abatacept and methotrexate. Arthritis Rheum. 2008 Apr; 58 (4): 953–963. DOI: 10.1002/art.23397.
7. Schiff M, Keiserman M, Codding C, et. al. Clinical response and tolerability to abatacept in patients with rheumatoid arthritis previously treated with infliximab or abatacept: open-label extension of the ATTEST Study. Ann Rheum Dis. 2011 Nov; 70 (11): 2003–7. DOI: 10.1136/annrheumdis-2011–200316.
8. Genovese MC, Becker JC, Schiff M, et. al. Abatacept for Rheumatoid Arthritis Refractory to Tumor Necrosis Factor α Inhibition. N Engl J Med 2005; 353: 1114–1123 Sept 15, 2005 DOI: 10.1056/NEJMoa050524.
9. Weinblatt M, Combe B, Covucci A, et. al. Safety of the Selective Costimulation Modulator Abatacept in Rheumatoid Arthritis Patients Receiving Background Biologic and Nonbiologic Disease-Modifying Antirheumatic Drugs. A OneYear Randomized, Placebo-Controlled Study. Arthritis Rheum. 2006 Sep; 54 (9): 2807–2816. DOI: 10.1002/art.22070.
10. Schiff M, Pritchard C, Huffstutter JE, et al. The 6-month safety and efficacy of abatacept in patients with rheumatoid arthritis who underwent a washout after anti-tumour necrosis factor therapy or were directly switched to abatacept: the ARRIVE trial. Ann Rheum Dis. 2009 Nov; 68 (11): 1708–14. DOI: 10.1136/ard.2008.099218.
11. Wells AF, Westhovens R, Reed DM, et. al. Abatacept plus methotrexate provides incremental clinical benefits versus methotrexate alone in methotrexate-naive patients with early rheumatoid arthritis who achieve radiographic nonprogression. J Rheumatol. 2011 Nov; 38 (11): 2362–8. DOI: 10.3899/jrheum.110054.
12. Emery P, Durez P, Dougados M, et. al. Impact of T-cell costimulation modulation in patients with undifferentiated infl ammatory arthritis or very early rheumatoid arthritis: a clinical and imaging study of abatacept (the ADJUST trial). Ann Rheum Dis. 2010 Mar; 69 (3): 510–6. DOI: 10.1136/ard.2009.119016.
13. Nüßlein HG, Alten R, Galeazzi M et al. Real-world effectiveness of abatacept for rheumatoid arthritis treatment in European and Canadian populations: a 6-month interim analysis of the 2-year, observational, prospective ACTION study. BMC Musculoskelet Disord. 2014 Jan 11; 15: 14. DOI: 10.1186/1471–2474–15–14.
14. Alten R, Mariette X, Lorenz H, et al Real-world predictors of 12–month intravenous abatacept retention in patients with rheumatoid arthritis in the ACTION observational study RMD Open 2017; 3: e000538. DOI: 10.1136/rmdopen-2017–000538.
15. Nüßlein HG, Alten R, Galeazzi M, et al. Prognostic factors for abatacept retention in patients who received at least one prior biologic agent: an interim analysis from the observational, prospective ACTION study. BMC Musculoskeletal Disorders. 2015; 16: 176. DOI: 10.1186/s12891–015–0636–9.
16. Alten R, Nüßlein H, Galeazzi M, et al. Decreased use of glucocorticoids in biological-experienced patients with rheumatoid arthritis who initiated intravenous abatacept: results from the 2-year ACTION study. RMD Open. 2016; 2 (1): e000228. DOI: 10.1136/rmdopen-2015–000228.
17. Gottenberg JE, Ravaud P, Cantagrel A, et al Positivity for anti-cyclic citrullinated peptide is associated with a better response to abatacept: data from the ‘Orencia and Rheumatoid Arthritis’ registry Annals of the Rheumatic Diseases 2012; 71: 1815–1819.
18. Truchetet M-E, Poursac N, Barnetche T, et al. Abatacept monotherapy compared with abatacept plus disease-modifying anti-rheumatic drugs in rheumatoid arthritis patients: data from the ORA registry. Arthritis Research & Therapy. 2016; 18: 72. DOI: 10.1186/s13075–016–0956–7.
19. Leffers HC, Østergaard M, Glintborg B, et al Efficacy of abatacept and tocilizumab in patients with rheumatoid arthritis treated in clinical practice: results from the nationwide Danish DANBIO registry Annals of the Rheumatic Diseases 2011; 70: 1216–1222.
20. Leffers HC, Østergaard M, Glintborg B et al. Three-Year Drug Survival and Effectiveness Of Abatacept and Tocilizumab In Patients with Rheumatoid Arthritis Treated In Routine Care. Results FromThe Nationwide Danish Danbio Registry. ABSTRACT NUMBER: 1442; 2013 ACR / ARHP Annual Meeting; acrabstracts.org/abstract/three-year-drug-survival-and-effectiveness-of-abatacept-and-tocilizumab-in-patients-with-rheumatoid-arthritis-treated-inroutine-care-results-from-the-nationwide-danish-danbio-registry.
21. Leffers HC, Østergaard M, Glintborg B et al. Two-Year Drug Survival and Treatment Effect of Abatacept and Tocilizumab in the Treatment of Rheumatoid Arthritis in Routine Care. Results From the Nationwide Danish Danbio Registry. ABSTRACT NUMBER: 1271; 2012 ACR / ARHP Annual Meeting; acrabstracts.org/abstract/two-year-drug-survival-and-treatment-effect-of-abatacept-and-tocilizumab-in-the-treatment-of-rheumatoid-arthritis-in-routine-care-results-from-the-nationwide-danish-danbio-registry.
22. Kubo S, Saito K, Hirata K et al. (2013) Abatacept inhibits radiographic progression in patients with rheumatoid arthritis: a retrospective analysis of 6 months of abatacept treatment in routine clinical practice. The ALTAIR study, Modern Rheumatology, 24: 1, 42–51, DOI: 10.3109/14397595.2013.854051.
23. Kubo S, Nakano K, Nakayamada S et al. Clinical, radiographic and functional efficacy of abatacept in routine care for rheumatoid arthritis patients: Abatacept Leading Trial for RA on Imaging Remission (ALTAIR) study. Clin Exp Rheumatol. 2016 Sep-Oct; 34 (5): 834–841. Epub 2016 Aug 31.
24. Horák P, Skácelová M, Hejduk K et al. Clin Rheumatol (2013) 32: 1451. doi.org/10.1007/s10067–013–2303–6. Abatacept and its use in the treatment of rheumatoid arthritis (RA) in the Czech Republic-data from the ATTRA registry.
25. Harrold LR, Reed GW, Kremer JM, et al. The comparative effectiveness of abatacept versus anti-tumour necrosis factor switching for rheumatoid arthritis patients previously treated with an anti-tumour necrosis factor. Annals of the Rheumatic Diseases. 2015; 74 (2): 430–436. DOI: 10.1136/annrheumdis-2013–203936.
26. Harrold LR, Litman HJ, Connolly SE, et al. A window of opportunity for abatacept in RA: is disease duration an independent predictor of low disease activity / remission in clinical practice? Clinical Rheumatology. 2017; 36 (6): 1215–1220. DOI: 10.1007/s10067–017–3588–7.
27. Schiff M, Poncet C, Le Bars M Efficacy and safety of abatacept therapy for rheumatoid arthritis in routine clinical practice. Int. J. Clin. Rheumatol. (2010) 5 (5), 581–591.
28. Takahashi N, Kojima T, Kaneko A et al. Clinical efficacy of abatacept compared to adalimumab and tocilizumab in rheumatoid arthritis patients with high disease activity. Clin Rheumatol. 2014 Jan; 33 (1): 39–47. DOI: 10.1007/s10067–013–2392–2. Epub 2013 Sep 22.
29. Takahashi N, Kojima T, Kaneko A et al. Longterm Efficacy and Safety of Abatacept in Patients with Rheumatoid Arthritis Treated in Routine Clinical Practice: Effect of Concomitant Methotrexate after 24 Weeks. The Journal of Rheumatology May 2015, 42 (5) 786–793; DOI: 10.3899/jrheum.141288.
30. Takahashi N, Kojima T, Terabe K et al. Clinical efficacy of abatacept in Japanese rheumatoid arthritis patients. Mod Rheumatol. 2013 Sep; 23 (5): 904–12. DOI: 10.1007/s10165–012–0760–4. Epub 2012 Sep 14.
31. Mochizuki T, Yano K, Ikari K et al. (2015): The efficacy of abatacept in Japanese patients with rheumatoid arthritis: 104 weeks radiographic and clinical results in clinical practice, Modern Rheumatology, DOI: 10.3109/14397595.2015.1109578.
32. Tanaka Y, Kubo S, Yamanaka H et al. Efficacy and safety of abatacept in routine care of patients with rheumatoid arthritis: Orencia (®) as Biological Intensive Treatment for RA (ORBIT) study. Mod Rheumatol. 2014 Sep; 24 (5): 754–62. DOI: 10.3109/14397595.2013.872862. Epub 2014 Jul 18.
33. Takahashi N, Fujibayashi T, Kida D et al. Concomitant methotrexate and tacrolimus augment the clinical response to abatacept in patients with rheumatoid arthritis with a prior history of biological DMARD use. Rheumatol Int. 2015 Oct; 35 (10): 1707–16. DOI: 10.1007/s00296–015–3283–4. Epub 2015 May 20.
34. Pascart T, Philippe P, Drumez E et al. Abatacept Monotherapy Versus Abatacept Plus Methotrexate for Treatment-Refractory Rheumatoid Arthritis. Am J Ther. 2017 Sep 12. DOI: 10.1097/MJT.0000000000000645.
35. Dudler J, Tuerk R, Handschin T et al. RAISE — rheumatoid arthritis independent Swiss treatment expectations and outcome: results for the abatacept subpopulation. Swiss Med Wkly. 2013 Dec 6; 143: w13849. DOI: 10.4414/smw.2013.13849.
36. Yasuda S, Ohmura K, Kanazawa H et al. Maintenance treatment using abatacept with dose reduction after achievement of low disease activity in patients with rheumatoid arthritis (MATADOR) — A prospective, multicenter, single arm pilot clinical trial. Mod Rheumatol. 2017 Nov; 27 (6): 930–937. DOI: 10.1080/14397595.2017.1286714. Epub 2017 Feb 16.
37. Finckh A, Neto D, Hernández MV et al. Abatacept after Rituximab in Rheumatoid Arthritis. a Pan-European Collaboration of RA Registries. ABSTRACT NUMBER: 504. 2014 ACR / ARHP Annual Meeting. acrabstracts.org/abstract/abatacept-after-rituximab-in-rheumatoid-arthritis-a-pan-european-collaboration-of-ra-registries.
38. Finckh A, Neto D, Hernández MV et al. Abatacept after Rituximab in Rheumatoid Arthritis. a Pan-European Collaboration of RA Registries. ABSTRACT NUMBER: 504. 2014 ACR / ARHP Annual Meeting. acrabstracts.org/abstract/abatacept-after-rituximab-in-rheumatoid-arthritis-a-pan-european-collaboration-of-ra-registries.
39. Das S, Vital EM, Horton S, et al Abatacept or tocilizumab after rituximab in rheumatoid arthritis? An exploratory study suggests non-response to rituximab is associated with persistently high IL-6 and better clinical response to IL-6 blocking therapy Annals of the Rheumatic Diseases Published Online First: 02 January 2014. DOI: 10.1136/annrheumdis-2013–204417.
40. Piantoni, S., Colombo, E., Tincani, A. et al. Predictive Factors of Discontinuation of Therapy with Abatacept in Patients with Rheumatoid Arthritis Clin Rheumatol (2016) 35: 1065. doi.org/10.1007/s10067–016–3185–1.
41. Лукина ГВ, Сигидин ЯА, Мазуров ВИ и др. Предварительные результаты применения абатацепта в клинической практике. В кн.: Генно-инженерные биологические препараты в лечении ревматоидного артрита. Под. ред. Е. Л. Насонова. Москва: ИМА-ПРЕСС; 2013. С. 386–387.
42. Мазуров ВИ, Долгих СВ и соавт. Опыт применения абатацепта в лечении больных ревматоидным артритом. Научно-практическая ревматология. 2011; 49 (6): 14–16. DOI: 10.14412/1995–4484–2011–513
43. Лапшина СА, Мясоутова ЛИ, Протопопов МС и соавт. Опыт применения абатацепта в терапии ревматоидного артрита в Республике Татарстан. Научно-практическая ревматология. 2012; 50 (6): 99–102. DOI: dx.doi.org/10.14412/1995–4484–2012–6.
44. Борисова М. А., Лукина Г. В., Сигидин Я. А. и соавт. Анализ эффективности и безопасности применения абатацепта при ревматоидном артрите: результаты 12-месячного наблюдения. Терапевтический архив. 2018; 05: 44–49. doi.org/10.26442/terarkh201890544–49
45. Борисова М. А. Комплексная оценка торможения костимуляции Т-лимфоцитов в современной терапии ревматоидного артрита: автореф. дис. Комплексная оценка торможения костимуляции Т-лимфоцитов в современной терапии ревматоидного артрита канд. мед. наук. ФГБНУ «НИИР» им. В. А. Насоновой, 2019
46. Sekiguchi M., Fujii T, Matsui K et al. Differences in Predictive Factors for Sustained Clinical Remission with Abatacept Between Younger and Elderly Patients with Biologic-naive Rheumatoid Arthritis: Results from the ABROAD Study. The Journal of Rheumatology Nov 2016, 43 (11) 1974–1983; DOI: 10.3899/jrheum.160051.
47. Pope JE, Rampakakis E, Sampalis J et al. The durability of abatacept as a first and subsequent biologic and improvement in HAQ from a large multi-site real-world study. Semin Arthritis Rheum. 2015 Apr; 44 (5): 499–505. DOI: 10.1016/j.semarthrit.2014.09.009. Epub 2014 Sep 28.
48. Борисова М. А., Лукина Г. В., Сигидин Я. А., Лучихина Е. Л., Каратеев Д. Е., Аронова Е. С., Глухова С. И. Сравнительная оценка эффективности и безопасности абатацепта у пациентов с разной длительностью ревматоидного артрита. Научно-практическая ревматология. 2016; 54 (6): 667–673. DOI: 10.14412/1995–4484–2016–667–673.
49. Gülfe A, Wallman JK, Kristensen LE. EuroQol-5 dimensions utility gain according to British and Swedish preference sets in rheumatoid arthritis treated with abatacept, rituximab, tocilizumab, or tumour necrosis factor inhibitors: a prospective cohort study from southern Sweden. Arthritis Research & Therapy. 2016; 18: 51. DOI: 10.1186/s13075–016–0950–0.
50. Jørgensen TS, Turesson C, Kapetanovic M, et al. EQ-5D utility, response and drug survival in rheumatoid arthritis patients on biologic monotherapy: A prospective observational study of patients registered in the south Swedish SSATG registry. Kuwana M, ed. PLoS ONE. 2017; 12 (2): e0169946. DOI: 10.1371/journal.pone.0169946.
51. Takeuchi T, Matsubara T, Ohta S, et al. Biologic-free remission of established rheumatoid arthritis after discontinuation of abatacept: a prospective, multicentre, observational study in Japan. Rheumatology (Oxford, England). 2015; 54 (4): 683–691. DOI: 10.1093/rheumatology/keu338.
52. Singh JA, Hossain A, Tanjong Ghogomu E et al. Biologics or tofacitinib for rheumatoid arthritis in incomplete responders to methotrexate or other traditional disease-modifying anti-rheumatic drugs: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2016 May 13; (5): CD 012183. DOI: 10.1002/14651858.CD 012183.
53. Nüßlein HG, Alten R, Galeazzi M et al. Efficacy and prognostic factors of treatment retention with intravenous abatacept for rheumatoid arthritis: 24-month results from an international, prospective, real-world study. Clin Exp Rheumatol. 2016 May-Jun; 34 (3): 489–99. Epub 2016 Mar 10.
54. Mariette X, Alten R, Nüßlein HG et al. The effect of body mass index on clinical response to abatacept as a first-line biologic for rheumatoid arthritis: 6-month results from the 2-year, observational, prospective ACTION study.
55. Harigai M, Ishiguro N, Inokuma S, et al. Postmarketing surveillance of the safety and effectiveness of abatacept in Japanese patients with rheumatoid arthritis. Modern Rheumatology. 2016; 26 (4): 491–498. DOI: 10.3109/14397595.2015.1123211.
56. Gottenberg JE, Courvoisier DS, Hernandez MV. Brief Report: Association of Rheumatoid Factor and Anti-Citrullinated Protein Antibody Positivity With Better Effectiveness of Abatacept: Results From the Pan-European Registry Analysis. Arthritis Rheumatol. 2016 Jun; 68 (6): 1346–52. DOI: 10.1002/art.39595.
57. Pieper J, Herrath J, Raghavan S CTLA4-Ig (abatacept) therapy modulates T cell effector functions in autoantibody-positive rheumatoid arthritis patients. CTLA4-Ig (abatacept) therapy modulates T cell effector functions in autoantibody-positive rheumatoid arthritis patients.
58. Yamazaki H, Hirano F, Takeuchi T et al. Simplified Disease Activity Index remission at month 6 is an independent predictor of functional and structural remissions at month 12 during abatacept treatment in patients with rheumatoid arthritis: A multi-center, prospective cohort study in Japan. Mod Rheumatol. 2017 Sep; 27 (5): 787–794. DOI: 10.1080/14397595.2016.1259715. Epub 2016 Dec 15.
Рецензия
Для цитирования:
Борисова М.А., Лукина Г.В. Анализ применения селективного модулятора костимуляции Т-лимфоцитов абатацепта в лечении ревматоидного артрита: данные международной клинической практики. Медицинский алфавит. 2019;1(18):13-23. https://doi.org/10.33667/2078-5631-2019-1-18(393)-13-23
For citation:
Borisova M.A., Lukina G.V. Analysis of the use of a selective modulator of cosmulation of T‑lymphocytes abatacept in the treatment of rheumatoid arthritis: data from international clinical practice. Medical alphabet. 2019;1(18):13-23. (In Russ.) https://doi.org/10.33667/2078-5631-2019-1-18(393)-13-23
Просмотров:
391
Послать статью по эл. почте 